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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Cardiac Perforation (2513)
Event Date 03/11/2024
Event Type  Injury  
Event Description
During a pulmonary vein isolation cryoablation a polarsheath was selected for use.A cardiac perforation occurred which required surgical repair to stabilize the patient.While performing the transseptal puncture using the non-bsc transseptal needle and polarsheath, the left atrial appendage was perforated.The perforation was surgically repaired to stabilize the patient.Furthermore, the physician alleges the transseptal needle was the cause of the perforation.It is unknown if the sheath will be available for return.
 
Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
 
Manufacturer Narrative
F12: serious injury/ illness/ impairment code added.The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.".
 
Event Description
During a pulmonary vein isolation cryoablation a polarsheath was selected for use.A cardiac perforation occurred which required surgical repair to stabilize the patient.While performing the transseptal puncture using the non-bsc transseptal needle and polarsheath, the left atrial appendage was perforated.The perforation was surgically repaired to stabilize the patient.Furthermore, the physician alleges the transseptal needle was the cause of the perforation.It is unknown if the sheath will be available for return.
 
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Brand Name
POLARSHEATH
Type of Device
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Manufacturer (Section D)
BOSTON SCIENTIFIC DE COSTA RICA S.R.L.
302 parkway
global park, la aurora
heredia
CS 
Manufacturer (Section G)
BOSTON SCIENTIFIC DE COSTA RICA S.R.L.
Manufacturer Contact
timothy degroot degroot
4100 hamline avenue north
dc a330
saint paul, MN 55112
6515826168
MDR Report Key18948825
MDR Text Key338229793
Report Number2124215-2024-16869
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/25/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/15/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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